Preparations are well underway for a proposed second phase of the EDCTP Programme, which is expected to start in January 2014 as part of Horizon 2020. It is expected to be established by ordinary legislation under Article 185 of the Treaty of the Functioning of the European Union. This article enables the European Union to participate in programmes undertaken by Member States. Such initiatives are proposed where there is a need for a dedicated implementation structure and a high level of commitment of the participating countries to integration at scientific, management and financial levels.

EDCTP aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria, with a focus on phase II and III clinical trials in sub-Saharan Africa. EDCTP supports multicentre projects that combine clinical trials, capacity building and networking.

Following an inclusive and consultative process that incorporated inputs and recommendations from various experts and stakeholders including an Independent External Expert Review; Impact Assessment Panel; an open public consultation; an all-EDCTP-constituency meeting; and a Member State Consensus it was agreed to expand on the scope of EDCTP building on the current achievements. This will include:

• Extension to involve all clinical trial phases I-IV including health services optimisation research
• Widening the scope to include other neglected infectious diseases
• Closer collaboration with industry, like-minded product development partners and development agencies
• Collaborative research with other developing countries outside sub-Saharan Africa when possible and desirable

To consolidate the achievements of the current programmes and prepare for EDCTP2, EDCTP has received funding from the European Commission for a programme of activities known as EDCTP-Plus which will be carried out during 2012 and 2013.

The aim of EDCTP-Plus is to lay the foundation for implementing and managing the EDCTP2 programme in view of the proposed expansion of scope and increased budget and to ensure the EU-Africa research partnership remains strong. These activities, distinct from the current EDCTP research activities, will be funded by Framework Programme 7 through a Support Action Grant.

EDCTP will be gathering the views of current and prospective member states and stakeholders during 2012 and 2013. Further information on these meetings and related activities will be published on the EDCTP website.

2014
Anticipated commencement of second EDCTP programme.

2012-2013
Preparation of a proposal by the European Commission and ordinary legislative process (codecision by the European Parliament and the Council). EDCTP to carry out preparatory EDCTP-Plus programme.

2012
The EDCTP Member State commitments will contribute to and support a future legislative process for EDCTP2, a proposal for which is expected to be drafted by the European Commission during 2012. In addition, EDCTP member states will also contribute to the Impact Assessment on EDCTP which is to be carried out by the European Commission in preparation for the ordinary legislative procedure.

2011
During 2011, a strategic business plan was drafted, revised and approved by the EDCTP General Assembly.  As part of this process, current EDCTP member states indicated the nature and value of their intended support to a future programme.

2010
Consensus meeting of current and potential new EDCTP Member States which was hosted by the Belgian Presidency of the European Union in Brussels from 27-28 September 2010.

If you would like any further information on the preparations for EDCTP2, please contact the EDCTP Secretariat.